Hims & Hers

Healthcare

VP,RegulatedDeviceEngineering

$300–350k Minnetonka, Minnesota, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Executive candidates.

The Brief

“VP, Regulated Device Engineering at Hims & Hers. Skills: Regulated device engineering, Product development, Regulatory compliance. Define strategic roadmap. Execute strategic roadmap”

What You'll Achieve.

Successful product development; Successful approval; Successful market adoption; Inspection readiness; Successful audits; Scalable production; Cost-effective production; Compliant production; Continuous improvement; Reduced time-to-market; Reduced cost efficiency

Industry & Context.

Healthcare
Problems you'll solve

Risk management; Usability engineering

What They're Looking For.

Must Have

Bachelor's degree in Mechanical Engineering, 15+ years of experience in medical device industry, Significant experience in Class II devices, Proven leadership experience overseeing R&D teams, Proven leadership experience overseeing product development pipelines, Deep knowledge of FDA regulations, Knowledge of 21 CFR Part 820, Knowledge of ISO 13485, Knowledge of ISO 14971, Demonstrated success leading products through regulatory clearance, Demonstrated success leading products through commercialization, Experience working closely with Quality and Regulatory functions, Experience in a design controlled environment

What You'll Do.

Define strategic roadmap

Execute strategic roadmap

Own resource allocation

Partner to identify new product opportunities

Build high-performing organization

Scale high-performing organization

Lead R&D developing medical devices

Ensure design control processes are robust

Ensure design control processes are compliant

Ensure design control processes are efficiently executed

Maintain disciplined product development processes

Ensure products meet FDA requirements

Ensure products meet international regulatory requirements

Ensure products meet quality system requirements

Partner with Quality leaders

Partner with Regulatory leaders

Support successful submissions

Champion culture of quality

Champion culture of compliance

Ensure inspection readiness

Ensure successful audits

Provide indirect leadership

Provide alignment across Clinical

Provide alignment across Manufacturing

Provide alignment across Supply Chain

Ensure clinical strategies support objectives

Collaborate with Manufacturing

Collaborate with Operations

Ensure scalable production processes

Ensure cost-effective production processes

Ensure compliant production processes

Drive continuous improvement

Identify technical risks

Mitigate technical risks

Identify regulatory risks

Mitigate regulatory risks

Identify operational risks

Mitigate operational risks

How You'll Work.

Team & Collaboration

Cross-functional influence; Quality and Regulatory leaders; Clinical, Manufacturing, Supply Chain

Process & Methodology

Product development pipelines

Full Job Description

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve.  Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit hims.com/about http://hims.com/about and hims.com/how-it-works http://hims.com/how-it-works . For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals http://www.hims.com/careers-professionals. ABOUT THE ROLE: The VP, Regulated Device Engineering is responsible for the overall leadership, strategy, and execution of the company’s regulated medical device business organization. This role owns end-to-end product development, from concept through commercialization, ensuring compliance with all FDA and global regulatory requirements while driving innovation, quality, and operational excellence. This leader will directly oversee Research & Development and have cross-functional influence with Quality, Regulatory Affairs, Clinical, and Manufacturing to ensure successful product development, approval, and market adoption. BUSINESS & STRATEGIC LEADERSHIP - Define and execute the strategic roadmap for the regulated devices portfolio, aligned with company growth objectives - Own budgeting, and resource allocation for the regulated devices business unit • Partner with executive leadership to identify new product opportunities • Build and scale a high-performing, cross-functional organization Product

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